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Bladder and Bowel Q2 2024

New drug candidate can improve therapy in bladder cancer patients

Doctor speaks with male patient
Doctor speaks with male patient

Catharina Svanborg

Chairman of the Board, Hamlet BioPharma AB and Professor, Lund University

With inputs from colleagues:
Martin Erixon, Jakob Testad, Sid Chinchankar, Björn Wullt, Ines Ambite, Hien Tran

A promising drug candidate has positive clinical effects in patients with bladder cancer. The number of tumours and tumour sizes were reduced in a majority of patients treated — and without severe side effects often associated with other treatments.

Bladder cancer is a disease which has a high likelihood of returning after treatment. Indeed, after the removal of the first tumour, cancer has been found to recur in 80% of these patients — and 15% go on to develop muscle-invasive disease. So, there’s an urgent need for safe and effective new treatments that could stop disease progression and prevent recurrences.

Drug candidate reduces bladder cancer tumour size

Now, a breakthrough may be on the horizon because Swedish-based pharmaceutical company Hamlet BioPharma has announced promising new data from a clinical trial of its drug candidate for the treatment of early non-muscle invasive bladder cancer, Alpha1H. Alpha1H is a synthetic drug candidate developed from HAMLET (human alpha-lactalbumin made lethal to tumour cells), originally discovered in human breast milk.

Combined data analysis from treated patients showed that higher doses of Alpha1H significantly reduced the size of 82% of tumours while lower doses significantly reduced the size of 45% of tumours, compared to a placebo group. Among other benefits, it’s hoped that the therapy could improve the treatment of early tumours and possibly reduce the risk of tumour regrowth post-surgery, paving the way for less invasive surgical interventions.

Alpha1H kills tumour cells with great precision
and is straightforward to produce in large amounts.

Catharina Svanborg

Way to treat patients without severe side effects

Alpha1H kills tumour cells with great precision and is straightforward to produce in large amounts,” says Catharina Svanborg, Chairman of the Board at Hamlet BioPharma. “What’s more, our studies show there is limited toxicity associated with its administration, so patients can be treated without experiencing the severe side effects associated with chemotherapy.” The biopharmaceutical company is now working towards a phase III clinical trial.

Fast-tracking drug candidate approval

The US Food and Drug Administration (FDA) has granted Fast Track Designation for Alpha1H, accelerating its approval process and potential to reach the US market and opening up dialogue with potential commercial partners. “Fast Track Designation is an exciting development,” says Jakob Testad, Chief Financial Officer at Hamlet BioPharma. “It demonstrates the promise of Alpha1H and underlines how vital it is to address bladder cancer and improve the quality of life for patients suffering from this disease.”

Hamlet BioPharma is an innovative biotechnology company that develops scientific discoveries made by scientists at Lund University into drugs for the treatment of cancer and infections. This joint effort addresses unmet medical needs in large patient groups in need of improved cancer treatments or alternatives to antibiotics.

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